Back to resultsLow Dose Methoxyflurane for Pain Relief During Minor Out-patient Urologic Procedures
Primary Purpose
Pain, Acute
Status
Unknown status
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Methoxyflurane, MEOF
Sponsored by
About this trial
This is an interventional treatment trial for Pain, Acute
Eligibility Criteria
Inclusion Criteria:
- Conscious adult patients >=
Patient is scheduled for cystoscopy And:
- BOTOX injections for Overactive Bladder /Neuogenic Detrusor Overactivity,
- Diagnostic hydrodistention for painful bladder syndrome
- Biopsy or cauterization of bladder tumors
- Biopsy, cauterization and/or injection of Hunner's lesions
- Visual urethrotomy/bladder neck incision=/- injection of stricture
- Evaluation of the complex urinary tract problems
- Patient (patient/or patient's authorization legal representative) should understand the nature of the study and provide written informed consent
- Patient is able to follow all study requirements and procedures and complete required questionnaires
Exclusion Criteria:
- An altered level of consciousness, due to any cause, including head injury, drugs,or alcohol
- Clinically significant renal impairment
- Women of child bearing potential who are pregnant or peri partum, including labour
- A history of liver dysfunction after previous MEOF use or other halogenated anesthetics
- Hypersensitivity to MEOF or other halogenated anesthetics, or to butylated hydroxytoluene
- Known or genetically susceptible to malignant hyperthermia or a history of severe adverse reactions in either patient or relatives
- Exacerbation of an underlying condition (i.e., chronic pain)
- Clinically evident or potential hemodynamic instability as per the opinion of the investigator
- Clinically evident respiratory impairment as per the opinion of the investigator
- Prior treatment with PENTHROX within 3 months
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
methoxyflurane
Arm Description
methoxyflurane
Outcomes
Primary Outcome Measures
Patient satisfaction measured using the Patient Global assessment of Medication Performance (GMP)at the time of discharge
Global assessment of Medication,which is an assessment, performed by the patient, of the patient's impression of how well the medication works. The patient is asked to rate the pain relief given by methoxyflurane using a 5-point likert scale - 0=poor;1=fair;2=good;3=very good;4=excellent
Secondary Outcome Measures
The Overall/Maximum pain intensity experienced at any point during the procedure using a numeric rating scale
Patient is asked to rate the intensity of the pain experienced using an 11-point numeric rating scale is used. A score of 0=no pain and a score of 10= worst pain possible
Percent patients requiring rescue medication
Documentation of the use of rescue medication post administration of methooxyflurane Documenting first time of use of rescue medication, type of medication administered,dose and route
Safety outcome measure to assess percentage of patients requiring rescue medication
Documentation of adverse events as safety outcome measure by the health care professional
Health professional impression of how well the medication worked measured using the Patient Global assessment of Medication Performance (GMP)at the time of discharge
Global assessment of Medication Performance, is an assessment, performed by the health care professional, of their impression of how well the medication works. The health care professional is asked a single question "rate the pain relief provided by methoxyflurane using a 5-point likert scale - 0=poor;1=fair;2=good;3=very good;4=excellent
Assessment of how well the medication fulfilled the patient's expectations of pain relief using the Fulfillment of of Pain Relief Expectation Scale
The patient is asked a single question "To what extent has your expectations regarding pain control been met?", using the Fulfillment of Pain Relief Expectation scale, which uses a 5-point Likert scale - 0=poor;1=fair;2=good;3=very good;4=excellent
Assessment of how well the medication fulfilled the health care professional's expectations of pain relief using the Fulfillment of of Pain Relief Expectation Scale
The health care professional is asked a single question "To what extent has your expectations regarding pain control been met?", using the Fulfillment of Pain Relief Expectation scale, which uses a 5-point Likert scale - 0=poor;1=fair;2=good;3=very good;4=excellent
Full Information
NCT ID
NCT04412642
First Posted
April 22, 2020
Last Updated
June 1, 2020
Sponsor
Sunnybrook Health Sciences Centre
1. Study Identification
Unique Protocol Identification Number
NCT04412642
Brief Title
Low Dose Methoxyflurane for Pain Relief During Minor Out-patient Urologic Procedures
Official Title
Pilot Study to Assess the Feasibility of Self-administered Low Dose Methoxyflurane for Pain Relief During Minor Out-patient Urologic Procedures
Study Type
Interventional
2. Study Status
Record Verification Date
June 2020
Overall Recruitment Status
Unknown status
Study Start Date
May 31, 2020 (Anticipated)
Primary Completion Date
September 30, 2020 (Anticipated)
Study Completion Date
December 31, 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sunnybrook Health Sciences Centre
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
The participant will be trained to self administer the drug and will be supplied with a PENTHROX commercial inhaler kit .The study nurse will train the participant and supervise its use during the procedure.Immediately following the procedure the participant will be asked to fill out two brief questionnaires. The study nurse will assess the participant for adverse event and will follow-up with a phone call 24 hours later.
Detailed Description
Many patients with chronic urological conditions require multiple and sometimes painful urological procedures. Ideally these procedures may be done in the cystoscopy suite without a general anesthetic. Low dose methoxyflurane, (MEOF)is a inhaled, self-administered non-opioid analgesic and has been approved by Health Canada's for the short-term relief of moderate to severe acute pain, associated with trauma or international medical procedures, in conscious adult patients. The brand name is PENTHROX.
This study is a single centre, pilot study to assess the feasibility of using a self-administrated, MEOF for pain relief during minor out-patient urological procedures. Eligible participants will receive a one time dose of the the study medication during a planned, outpatient urological procedure done under cystoscopy in the Cystoscopy clinic
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Acute
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Masking Description
no masking
Allocation
N/A
Enrollment
10 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
methoxyflurane
Arm Type
Other
Arm Description
methoxyflurane
Intervention Type
Drug
Intervention Name(s)
Methoxyflurane, MEOF
Other Intervention Name(s)
Penthrox
Intervention Description
As soon as possible following enrollment and initial procedures, the patient will be supplied with a PENTHROX™ kit which includes one inhaler containing 3 mL of MEOF for pain management. A member of the research team will train the patient to self-administer MEOF. PENTHROX™ is an approved (trademarked) product in Canada and is commercially available in a combination blister pack with one 3 mL sealed bottle and one PENTHROX™ inhaler with the Activated Carbon (AC) chamber.
Primary Outcome Measure Information:
Title
Patient satisfaction measured using the Patient Global assessment of Medication Performance (GMP)at the time of discharge
Description
Global assessment of Medication,which is an assessment, performed by the patient, of the patient's impression of how well the medication works. The patient is asked to rate the pain relief given by methoxyflurane using a 5-point likert scale - 0=poor;1=fair;2=good;3=very good;4=excellent
Time Frame
end of procedure
Secondary Outcome Measure Information:
Title
The Overall/Maximum pain intensity experienced at any point during the procedure using a numeric rating scale
Description
Patient is asked to rate the intensity of the pain experienced using an 11-point numeric rating scale is used. A score of 0=no pain and a score of 10= worst pain possible
Time Frame
during the procedure
Title
Percent patients requiring rescue medication
Description
Documentation of the use of rescue medication post administration of methooxyflurane Documenting first time of use of rescue medication, type of medication administered,dose and route
Time Frame
during the procedure
Title
Safety outcome measure to assess percentage of patients requiring rescue medication
Description
Documentation of adverse events as safety outcome measure by the health care professional
Time Frame
During the procedure;post procedure and at 24 hours post procedure (phone contact)
Title
Health professional impression of how well the medication worked measured using the Patient Global assessment of Medication Performance (GMP)at the time of discharge
Description
Global assessment of Medication Performance, is an assessment, performed by the health care professional, of their impression of how well the medication works. The health care professional is asked a single question "rate the pain relief provided by methoxyflurane using a 5-point likert scale - 0=poor;1=fair;2=good;3=very good;4=excellent
Time Frame
end of procedure
Title
Assessment of how well the medication fulfilled the patient's expectations of pain relief using the Fulfillment of of Pain Relief Expectation Scale
Description
The patient is asked a single question "To what extent has your expectations regarding pain control been met?", using the Fulfillment of Pain Relief Expectation scale, which uses a 5-point Likert scale - 0=poor;1=fair;2=good;3=very good;4=excellent
Time Frame
end of procedure
Title
Assessment of how well the medication fulfilled the health care professional's expectations of pain relief using the Fulfillment of of Pain Relief Expectation Scale
Description
The health care professional is asked a single question "To what extent has your expectations regarding pain control been met?", using the Fulfillment of Pain Relief Expectation scale, which uses a 5-point Likert scale - 0=poor;1=fair;2=good;3=very good;4=excellent
Time Frame
end of procedure
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Conscious adult patients >=
Patient is scheduled for cystoscopy And:
BOTOX injections for Overactive Bladder /Neuogenic Detrusor Overactivity,
Diagnostic hydrodistention for painful bladder syndrome
Biopsy or cauterization of bladder tumors
Biopsy, cauterization and/or injection of Hunner's lesions
Visual urethrotomy/bladder neck incision=/- injection of stricture
Evaluation of the complex urinary tract problems
Patient (patient/or patient's authorization legal representative) should understand the nature of the study and provide written informed consent
Patient is able to follow all study requirements and procedures and complete required questionnaires
Exclusion Criteria:
An altered level of consciousness, due to any cause, including head injury, drugs,or alcohol
Clinically significant renal impairment
Women of child bearing potential who are pregnant or peri partum, including labour
A history of liver dysfunction after previous MEOF use or other halogenated anesthetics
Hypersensitivity to MEOF or other halogenated anesthetics, or to butylated hydroxytoluene
Known or genetically susceptible to malignant hyperthermia or a history of severe adverse reactions in either patient or relatives
Exacerbation of an underlying condition (i.e., chronic pain)
Clinically evident or potential hemodynamic instability as per the opinion of the investigator
Clinically evident respiratory impairment as per the opinion of the investigator
Prior treatment with PENTHROX within 3 months
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Joanne M Lawrence, RN,BSc.
Phone
416-480-6100
Ext
2309
Email
joannelawrence@bell.net
First Name & Middle Initial & Last Name or Official Title & Degree
Sender Herschorn, MD,FRSC
Phone
416-480-4733
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sender Herschorn, MD, FRSC
Organizational Affiliation
Sunnybrook Health Sciences Centre
Official's Role
Principal Investigator
12. IPD Sharing Statement
Learn more about this trial
Low Dose Methoxyflurane for Pain Relief During Minor Out-patient Urologic Procedures
We'll reach out to this number within 24 hrs